The Humanized Monoclonal Antibody Milatuzumab for Refractory Chronic Lymphocytic Leukemia (CLL)
Phase I-II Trial of the Anti CD74 Monoclonal Antibody-Milatuzumab as a Single Agent in Refractory Chronic Lymphocytic Leukemia
1 other identifier
interventional
15
1 country
1
Brief Summary
The purpose of this study is to determine whether Milatuzumab is effective in patients with refractory chronic lymphocytic leukemia, and also to find out in which range of doses is a response seen.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Apr 2009
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2009
CompletedFirst Posted
Study publicly available on registry
March 25, 2009
CompletedStudy Start
First participant enrolled
April 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedJune 2, 2010
September 1, 2009
2 years
March 24, 2009
June 1, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Response to treatment
12 weeks, 24 weeks
Interventions
Milatuzumab will be given at a starting dose of 120 mg/m2, and then if no response or significant toxicity is seen after a total of 12 weeks, the dose will be gradually increased, by 120 mg/ m2 every four weeks, for a total of another 12 weeks.
Eligibility Criteria
You may qualify if:
- B-CLL confirmed according to NCI criteria
- CLL relapsed or refractory to prior antineoplastic therapy
- Signs of progressive disease; at least one:
- B symptoms
- lymphocyte doubling time of \< 6 months
- symptomatic lymphadenopathy or splenomegaly
- cytopenias due to bone marrow failure)
- Age \> 18 years, and less then 80
- Serum ALAT, ASAT, bilirubin, creatinine \< 2x upper limit of normal
- Life expectancy \> 6 months
- Patient's written informed consent
You may not qualify if:
- Active bacterial or viral infection
- Hypersensitivity to humanized monoclonal antibodies
- Concurrent antineoplastic treatment for CLL or other malignant disease
- Absolute neutrophil count \< 1.5 K/
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kaplan Medical Centerlead
- Gilead Sciencescollaborator
Study Sites (1)
Kaplan Medical Center
Rehovot, 76100, Israel
Related Publications (1)
Binsky I, Haran M, Starlets D, Gore Y, Lantner F, Harpaz N, Leng L, Goldenberg DM, Shvidel L, Berrebi A, Bucala R, Shachar I. IL-8 secreted in a macrophage migration-inhibitory factor- and CD74-dependent manner regulates B cell chronic lymphocytic leukemia survival. Proc Natl Acad Sci U S A. 2007 Aug 14;104(33):13408-13. doi: 10.1073/pnas.0701553104. Epub 2007 Aug 8.
PMID: 17686984BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michal Haran, MD
Kaplan Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 24, 2009
First Posted
March 25, 2009
Study Start
April 1, 2009
Primary Completion
April 1, 2011
Study Completion
April 1, 2012
Last Updated
June 2, 2010
Record last verified: 2009-09